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A Center Based Early Intervention Program For Preschoolers With Developmental Disorders

NCT ID: NCT04026386

Last Updated: 2025-11-12

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

75 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-10-19

Study Completion Date

2034-12-30

Brief Summary

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The purpose of this study is to examine the effectiveness of a 12-week early intervention program that will include 12 weekly hours in an intensive center-based preschool environment or in the home to treat social communication deficits in children with developmental disorders. The study will include children with developmental disorders, such as Autism Spectrum Disorder, neurogenetic disorders, or intellectual disability.

Detailed Description

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Conditions

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Development Disorder, Child Developmental Disability Development Delay Autism Spectrum Disorder

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Center Based or In-Home Early Intervention Program

Group Type EXPERIMENTAL

Center Based or In Home Early Intervention Program

Intervention Type BEHAVIORAL

This is a 12-week early intervention program that will include 12 weekly hours of treatment in an intensive center-based preschool environment or in home to treat social communication deficits in children with developmental disorders.

Interventions

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Center Based or In Home Early Intervention Program

This is a 12-week early intervention program that will include 12 weekly hours of treatment in an intensive center-based preschool environment or in home to treat social communication deficits in children with developmental disorders.

Intervention Type BEHAVIORAL

Eligibility Criteria

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Inclusion Criteria

* Diagnosis of Developmental Disorder, such as Autism Spectrum Disorder, neurogenetic disorder, or intellectual disability, based on clinical interview;
* Boys and girls between 2.0 years and 5.11 years at time of enrollment;
* Ability to participate in the testing procedures to the extent that valid standard scores can be obtained.

Exclusion Criteria

* Current or lifetime diagnosis of severe psychiatric disorder (e.g., bipolar disorder, etc.);
* Lack of availability during program hours.
Minimum Eligible Age

2 Years

Maximum Eligible Age

5 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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John & Marcia Goldman Foundation

UNKNOWN

Sponsor Role collaborator

Stanford University

OTHER

Sponsor Role lead

Responsible Party

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Antonio Hardan

Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Antonio Hardan, MD

Role: PRINCIPAL_INVESTIGATOR

Stanford University

Locations

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Stanford University School of Medicine

Stanford, California, United States

Site Status RECRUITING

Countries

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United States

Central Contacts

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Madeleine Clark, BS

Role: CONTACT

Phone: (650) 736-1235

Email: [email protected]

Robin Libove, BS

Role: CONTACT

Phone: (650) 736-1235

Email: [email protected]

Facility Contacts

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Madeleine Clark, BS

Role: primary

Anna Oft, BS

Role: backup

Other Identifiers

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IRB-52348

Identifier Type: -

Identifier Source: org_study_id